# A framework for biosafety assessment of microbial strains in Biotechnology applications

## TL;DR

This paper introduces a framework to assess biosafety risks of 40 microbial strains used in biotechnology, focusing on factors like pathogenicity and environmental persistence.

## Contribution

The novel contribution is a data-driven biosafety assessment framework emphasizing strain-specific evaluations over taxonomy-based assumptions.

## Key findings

- 84% of biosafety risk variation was unrelated to microbial taxonomy.
- 76% of fungal strains induced high immune responses, and 68% persisted in simulated environments for over 30 days.
- 71% of gram-negative bacteria had virulence genes and showed cytotoxicity in human cells.

## Abstract

Biosafety refers to the principles and practices that prevent unintentional exposure to biological agents and limit their potential
harm to humans and the environment. Therefore, we developed a comprehensive biosafety assessment framework for 40 microbial strains used
in biotechnology, evaluating five key parameters: pathogenicity, immunogenicity, environmental persistence, genetic stability, and
taxonomy. Principal component analysis showed that 84% of the risk variation was unrelated to taxonomy, emphasizing the need for
strain-specific evaluations. Among the strains assessed, 76% of fungi triggered high levels of TNF-α and IL-6 in immune cell assays, and
68% persisted beyond 30 days in simulated environmental conditions. Meanwhile, 71% of gram-negative bacteria carried virulence genes
(et al., hlyA, invA) and exhibited significant cytotoxicity in human cell cultures. These findings support a
data-driven, parameter-based approach for advancing biosafety standards in modern biotechnology.